Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Collaborators: First Affiliated Hospital of Wenzhou Medical University; Jinhua Central Hospital; Ningbo Medical Center Lihuili Eastern Hospital; People's Hospital of Quzhou; Quzhou People’s Hospital; The Central Hospital of Lishui City; Zhejiang Provincial People's Hospital; Zhejiang Provincial People’s Hospital
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.

2. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)

3. No evidence of distant metastasis (M0)

4. Performance status: KPS>70

5. With normal liver function test (ALT, AST <1.5ULN)

6. Renal: creatinine clearance >60ml/min

7. Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.

8. With controlled blood glucose for diabetes patients

9. Written informed consent

10. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma

2. Age >65 or <18

3. With a history of renal disease

4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)

5. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)

6. Patient is pregnant or lactating

7. Peripheral neuropathy

8. Emotional disturbance