Trial Title:
Reduced-target Resection After Induction Chemotherapy in Resectable Recurrent Nasopharyngeal Carcinoma
NCT ID:
NCT05877872
Condition:
Nasopharyngeal Carcinoma
De-escaltion Therapy
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Immunomodulating Agents
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Reduced-target resection
Description:
Patients receive surgery according to pSTV-post-IC.
Arm group label:
Reduced-target resection group
Intervention type:
Procedure
Intervention name:
Full-target resection
Description:
Patients receive surgery according to pSTV-pre-IC.
Arm group label:
Full-target resection group
Intervention type:
Drug
Intervention name:
Adjuvant immunotherapy
Description:
Toripalimab(240 mg d1) continually applied since 1-2 weeks after surgery until confirmed
disease progression, death, unacceptable toxicity, withdrawal of consent, investigator
decision, or 1 year.
Arm group label:
Full-target resection group
Arm group label:
Reduced-target resection group
Summary:
The goal of this clinical trial is to compare efficacy of two different resection
extension in patients with resectable recurrent nasopharyngeal carcinoma after induction
chemotherapy. The main question it aims to answer is that whether tumor regress areas
after induction chemotherapy required complete resection. Patients will be randomly
assigned to receive reduced-target resection or full-target resection after induction
chemotherapy. Researchers will compare these two groups to see if the efficacy of
reduced-target resection is not inferior to full-target resection.
Detailed description:
Induction chemotherapy is often used preoperatively to reduce the size, extent, or stage
of the tumor, thereby making the surgery more likely to be successful. However, there are
still many patients with marginal recurrence after induction chemotherapy combined with
surgery. With the progress of treatment methods, high efficient and low toxicity adjuvant
immunotherapy is helpful to kill the minimal residual tumor lesions. Hence, whether
complete resection is still necessary for areas with tumor regression after induction
chemotherapy needs further investigation. Because of the organs at risk around the
nasopharynx, any treatment strategy that can reduce the scope of tumor resection is of
great significance. Therefore, by comparing reduced-target resection and full-target
resection after induction chemotherapy, we aim to investigate whether reduced-target
resection after induction chemotherapy is not inferior to full-target resection, but it
greatly reduces the risk and difficulty of surgery. Even if marginal recurrence occurs
after reduced-target resection, early intervention can still be performed through closely
follow-up, without affecting the overall survival of patients.
When patients enroll this study, GTV-pre-IC (Gross Tumor Volume before induction
chemotherapy) was defined according to the magentic resonance imaging before induction
chemotherapy and GTV-post-IC (Gross Tumor Volume after induction chemotherapy) defined
according to the magentic resonance imaging after induction chemotherapy. The pSTV-pre-IC
(planing Surgical Tumor Volume before induction chemotherapy) and pSTV-post-IC (planing
Surgical Tumor Volume after induction chemotherapy) were the GTV-pre-IC and GTV-post-IC
plus an additional 0.5-1.0 cm peripheral mucosa margin and a 2-3 mm basal margin on the
surface skull base. Patiens in experiment group will receive reduced-target resection,
which resection extension is according to pSTV-post-IC. While patients in control group
will receive full-target resection, which is according to pSTV-pre-IC. After surgery, the
acturial resection area was defined as aSTV, which would be used for quality control. If
aSTV does not cover pSTV, patients will be excluded in per-protocol set.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The recurrence time is more than 6 months from the end of radiotherapy.
2. Histologically confirmed recurrent nasopharyngeal carcinoma.
3. Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in
nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement);
recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is
more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is
confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the
internal carotid artery and cavernous sinus) (according to the 8th edition of
American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal
carcinoma). If the tumor invaded the internal carotid artery, or the instance from
the internal carotid artery was less than 0.5cm, but the invasion area did not
exceed the external edge of the internal carotid artery, the patients could be
enrolled after internal carotid artery pretreatment (including internal carotid
artery embolization or stent implantation).
4. After 3 cycles induction chemotherapy (Platinum based chemotherapy
[gemcitabine/paclitaxel and platinum] and immunotherapy[PD-1/PD-L1 antibody] or a
GAP regmen[gemcitabine, Apatinib and immunotherapy[PD-1/PD-L1 antibody]), patients
achieved at least PR according to RECIST criteria, and the reduction of pSTV after
induction chemotherapy more than 50%.
5. Given written informed consent.
Exclusion Criteria:
1. Karnofsky Performance Status (KPS) ≤70.
2. Has severe medical disorder, important organ dysfunction, and/or a substantial
history of mental illness.
3. Tumor confined to the roof or the posterior wall of nasopharynx, without expected
benefit from reduced-target resection.
4. Unresectable recurrent regional lymph node diseases (recurrent N1-3) with
prevertebral fascia, cervical vertebrae, or common/internal carotid artery
involvement (according to the 8th edition of AJCC staging system).
5. Clinically diagnosed with metastatic NPC.
6. Has known subjects with other malignant tumors (except for cured skin basal cell
carcinoma or cervical carcinoma in situ).
7. Received a systematic or local glucocorticoid therapy within 4 weeks of planned
start of study treatment.
8. Suffered from diseases need long-term treatment with immunosuppressive drugs, or
required systematic or local glucocorticoid therapy with immunosuppressive doses.
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T
lymphocyte-associated antigen 4 (CTLA-4) agent.
9. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis,
nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator
therapy). Patients with skin disease that doesn't require systemic treatment (e.g.,
vitiligo, psoriasis, or alopecia) will be allowed to enroll.
10. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface
antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml
or hepatitis C virus (HCV) antibody positive.
11. Has received a live vaccine within 4 weeks of planned start of study treatment.
Pregnancy or breast feeding.
12. Cannot complete regular follow-up.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming-Yuan Chen, MD,PhD
Phone:
86-20-8734-2422
Email:
chmingy@mail.sysu.edu.cn
Start date:
May 20, 2023
Completion date:
March 30, 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Foshan
Agency class:
Other
Collaborator:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05877872
