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Completed

NCT Number: NCT03175939

Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) biopsy-proven carcinoma of the nasopharynx,
  • (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
  • (3) normal renal function (Cr < 1.6 mg/dl),

Exclusion criteria

  • open-neck lymph node biopsy
  • previous chemotherapy or radiotherapy to the head and neck region
  • distant metastasis or other malignant diseases except skin cancer

Treatment and study plan

Radiotherapy

Radiation

External beam radiotherapy with curative intent, at least 66 Gy

Cisplatin

Drug

cisplatin IV injection over 3 hours

Other names: CDDP

5-FU

Drug

5-FU IV 24 hours continuous infusion

Other names: 5-fluorouracil

Primary outcomes

  1. Distant-metastasis-free survival

    Time frame: 5 years

    percentage of patients who survived and has no distant metastasis

Secondary outcomes

  1. overall survival

    Time frame: 5 years

    percentage of patients who survived

  2. disease-free survival

    Time frame: 5 years

    percentage of patients who survived and had no disease recurrence

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy

Important dates

Study start
1998
Primary completion
2008
Study completion
2014
First posted
Jun 5, 2017
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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