Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

Hong Kong Nasopharyngeal Cancer Study Group Limited

Status and phase: Completed; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Capecitabine; Drug: Adjuvant chemotherapy using PF (5-Fluorouracil ); Drug: Induction chemotherapy using PF (5-Fluorouracil)

Study type: Interventional

Funder types: Other

Identifiers

NCT00379262

NPC-0501 Trial

Details and patient eligibility

About

The objectives of this clinical study are threefold:

1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

Full description

1. primary objectives include

   1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
   2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
   3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.

2. secondary objectives include

   1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
   2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.

Enrollment: 803 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
• non-keratinizing or undifferentiated type
• stage III-IVB (by AJCC/UICC 6th edition)
• ECOG Performance status less or equal to 2
• Marrow: WBC >= 4 and platelet >=100
• Renal: creatinine clearance >=60
• Informed consent

Exclusion criteria

• Primary treatment with palliative intent
• WHO type I squamous cell carcinoma or adenocarcinoma
• Evidence of distant metastases
• Patient is pregnant or lactating
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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803 participants in 6 patient groups

1A

Experimental group

Description:

Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy

Treatment:

Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )

1B

Experimental group

Description:

Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy

Treatment:

Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )

2A

Experimental group

Description:

Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy

Treatment:

Drug: Induction chemotherapy using PF (5-Fluorouracil)

2B

Experimental group

Description:

Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy

Treatment:

Drug: Induction chemotherapy using PF (5-Fluorouracil)

3A

Experimental group

Description:

Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy

Treatment:

Drug: Capecitabine

3B

Experimental group

Description:

Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy

Treatment:

Drug: Capecitabine