Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC

NCT03890185 | Unknown Phase 2

• 1 other identifier: 2121 063
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

The central hypothesis is to test Low Dose Fraction Radiotherapy (LDFRT), as a potentiator of Docetaxel and Cisplatin efficacy in locally advanced nasopharyngeal cancer.

Conditions

Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of chemo and radiation toxicities

  Chemotherapy and acute radiation toxicities as evaluated using the revised NCI (CTCAE) Version 4.03

  Three years

Secondary Outcomes (1)

• Distant and loco regional failure

  Three years

Study Arms (2)

A: Chemo+RT low dose

EXPERIMENTAL

Chemo + Low dose RT: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin (CDDP) 75mg/m2 IV D1 and radiation therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for a total of 2 cycles every 21 days.

Combination Product: Chemo + Low dose RT; Drug: Chemo alone

B: Chemo alone

ACTIVE COMPARATOR

Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.

Combination Product: Chemo + Low dose RT; Drug: Chemo alone

Interventions

Chemo + Low dose RT COMBINATION_PRODUCT

Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin 75mg/m2 IV D1.Radiathion therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for total of 2 cycles every 21 days.

Also known as: Chemotherapy, Low Dose Radiation Therapy

A: Chemo+RT low dose; B: Chemo alone

Chemo alone DRUG

Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.

Also known as: Chemotherapy

A: Chemo+RT low dose; B: Chemo alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• WHO II-III carcinoma of the nasopharynx, histologically proven.
• Locally advanced stage III and IV (minimal intracranial extension only) with absence of distant metastases.
• Age between 18 and 70 years.
• ECOG performance status 0-2.
• Neutrophils ≥ 1000 \* 109/l.
• Platelets: ≥ 100 \* 109/l.
• Hemoglobin: ≥ 9 g/dl
• Adequate hepatic function, defined as follows within 2 weeks prior to registration:
• Total bilirubin is normal
• AST (SGOT) and ALT (SGPT) \<= 2.5 \* upper limit of normal (ULN) of each center.
• Alkaline phosphatase \<= 2.5 \* ULN.
• Patient who has given his/her written consent before any specific procedure of the protocol.

You may not qualify if:

• Patients who present stage I, IIa, IIb and IVc.
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is permitted;
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Head and neck surgery of the primary tumor or lymph nodes prior to registration, with the exception of incisional or excisional biopsies.
• Patients receiving other experimental therapeutic cancer treatment;
• Blood pressure at baseline \> 150/100 mmHg;
• Peripheral neuropathy CTCAE, v. 4.0 h grade 2
• Severe, active co-morbidity, defined as follows:
• Major medical or psychiatric illness, which in the investigators' opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy.
• Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months, or other cardiac compromise that in the judgment of the investigator will preclude the safe administration of a study drug.
• Acquired Immune Deficiency.
• Prior allergic reaction to the study drug(s) involved in this.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nasser Alrajhi, MD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: March 26, 2019
• Study Start: October 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 26, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share